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      • KCI등재

        Treatment of Breast Cancer-Related Lymphedema With Topical Tacrolimus: A Prospective, Open-Label, Single-Arm, Phase II Pilot Trial

        Frederik C. Gulmark Hansen,Mads Gustaf Jørgensen,Jens Ahm Sørensen 한국유방암학회 2023 Journal of breast cancer Vol.26 No.1

        Purpose: Breast cancer-related lymphedema (BCRL) is a chronic, progressive side effect of breast cancer treatment, occurring in one-third of patients treated with axillary lymph node dissection and nodal radiotherapy. Cluster of differentiation 4-positive (CD4+) cells plays a key role in BCRL by facilitating inflammation and inhibiting lymphangiogenesis. Tacrolimus is an anti-inflammatory and immunosuppressive macrolide that targets CD4+ cells. Treatment of lymphedema with topical tacrolimus has revealed promising results in preclinical trials. This clinical trial was aimed at evaluating the feasibility, safety, and effect of tacrolimus in women with stage I or II BCRL, according to the International Society of Lymphology. Methods: We conducted this open-label, single-arm, phase II pilot trial from September 2020 to April 2021. Eighteen women with BCRL stage I or II BCRL were treated with topical tacrolimus for 6 months and followed up at 3 and 6 months. The primary outcome was arm volume, and secondary outcomes were the lymphedema index (L-Dex), health-related quality of life (HRQoL), lymph flow and function, and safety and feasibility of the trial design. Results: The mean lymphedema arm volume and L-Dex reduced significantly by 130.44 ± 210.13 mL (p < 0.05; relative reduction: 3.6%) and 3.54 ± 4.98 (p < 0.05), respectively, and health-related quality of life scores was improved significantly (p < 0.05). According to the MD Anderson scale, in terms of lymph flow and function, three patients (16.7%) showed improvement, while none showed worsening. Lymph flow or function showed no change according to the Arm Dermal Backflow scale. Conclusion: In this trial, treatment with tacrolimus was safe and feasible in women with stage I or II BCRL. Tacrolimus alleviated BCRL in terms of improved arm volume, L-Dex, and HRQoL. Assessments of lymph flow and function were positive, although inconclusive. Larger randomized controlled trials are required to verify these findings. Trial Registration: ClinicalTrials.gov Identifier: NCT04541290

      • KCI등재

        A simple clinical assessment of breast animation deformity following direct-to-implant breast reconstruction

        Diana Lydia Dyrberg,Gudjon Leifur Gunnarsson,Camilla Bille,Jens Ahm Sørensen,Jørn Bo Thomsen 대한성형외과학회 2019 Archives of Plastic Surgery Vol.46 No.6

        Background A high incidence of breast animation deformity (BAD) has been reported followingimmediate breast reconstruction with subpectorally placed implants. The aim of thisstudy was to assess and compare the incidence of BAD in women who underwent either subpectoralor prepectoral immediate breast reconstruction. Therefore, we developed a gradingtool and tested its reproducibility in a clinical setting. Methods Video recordings of 37 women who had undergone unilateral or bilateral immediatebreast reconstruction were evaluated by two consultant plastic surgeons. The degree ofBAD was assessed by our grading tool, named the Nipple, Surrounding Skin, Entire Breast(NSE) grading scale, which evaluates the degree of tissue distortion in three areas of thebreast. Blinded assessments were performed twice by each observer. Results Eighteen patients were reconstructed with subpectoral implant placement and 19with prepectoral implant placement. Using the NSE grading scale, we found a significant differencein the degree of BAD between the groups, in favor of patients who underwent prepectoralimmediate breast reconstruction (0.2 vs. 4, P=0.000). Inter- and intraobserver agreementwas moderate (74%) to strong (88%). Conclusions The incidence and severity of BAD was significantly lower in women reconstructedwith a prepectorally placed implant than in those who underwent subpectoral immediatebreast reconstruction. All patients reconstructed using the subpectoral techniquehad some degree of BAD. The inter- and intraobserver agreements were high when using theNSE grading scale, suggesting it is an easy-to-use, reproducible scale for assessing BAD inwomen who undergo immediate breast reconstruction.

      • KCI등재

        Breast animation deformity

        Diana Lydia Dyrberg,Camilla Bille,Gudjon Leifur Gunnarsson,Tove Faber Frandsen,C. Andrew Salzberg,Jens Ahm Sørensen,Jørn Bo Thomsen 대한성형외과학회 2019 Archives of Plastic Surgery Vol.46 No.1

        Breast animation deformity (BAD) has been reported to occur after submuscular implant placement following breast augmentation and immediate breast reconstruction. Despite its apparent impact on patients’ quality of life, BAD has only recently become a topic of general concern. Its incidence and etiology have yet to be established. The aim of this systematic review was to identify papers that clearly defined and classified BAD and described how the degree of animation was assessed. We performed a search in PubMed and Embase. Studies meeting the inclusion criteria that described BAD after implant-based breast augmentation or immediate breast reconstruction were included. After screening 866 publications, four studies were included: three describing BAD after breast augmentation and one describing BAD after immediate breast reconstruction. The median percentage of patients with some degree of BAD was 58%. The highest percentages were found in patients operated on using the Regnault technique or the dual-plane technique (73%–78%). The lowest percentages were found following the dual-plane muscle-splitting technique (30%) and the triple-plane technique (33%). We found no studies meeting the inclusion criteria that analyzed BAD after prepectoral implant placement. This review of the current literature suggests that the degree of BAD is proportional to the degree of muscle involvement. Evidence is scarce, and the phenomenon seems to be underreported. Future comparative studies are warranted.

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